Abstract 4582
Background
Few data are available on the treatment of ABC in older adults due to exclusion of this population from clinical trials. POLARIS is a real-world observational study in patients (pts) with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2-) ABC receiving PAL in the United States (US) and Canada. This sub-group analysis evaluates outcomes in geriatric pts aged ≥70 years (y).
Methods
Baseline (BL) demographics, clinical characteristics, dose modifications, ECOG performance status (PS), and adverse events (AEs) in the first 6 months (mo) were analyzed. Frailty and functional status were assessed with the Geriatric 8 (G8) and Activities of Daily Living (ADL) screening tools, respectively. G8 and ADL were captured at BL, monthly for the first 3 mo, and every 3 mo thereafter. G8 and ADL scores were stratified by severity (G8: ≤14=impaired; >14=normal; ADL: ≤5=impaired, >5=normal). Associations between treatment outcomes (ECOG PS, dose modifications, AEs) and G8 and ADL scores at BL and 6 mo were analyzed with descriptive statistics and the Fisher-Freeman-Halton test.
Results
Of 860 pts enrolled at 114 US sites, 282 (33%) were ≥70 y and had been observed for ≥6 mo. At BL, 61% of this group had G8 scores ≤14, and 21% had ADL scores ≤5. At 6 mo, 67% had G8 scores ≤14, 20% had ADL scores ≤5. BL G8 and ADL were associated with ECOG PS at BL and 6 mo, ADL at 6 mo was associated with ECOG PS at 6 mo, and G8 at 6 mo was marginally associated with ECOG PS at 6 mo (Table). No association was seen between ECOG PS, ADL, or G8 scores and dose modifications or AEs.Table:
365P Cross tabulations of ADL and G8 with ECOG PS
Baseline ECOG PS = 0 | 6 mo ECOG PS = 0 | |
---|---|---|
# of pts with ECOG PS = 0 / # pts with ADL or G8 score | # of pts with ECOG PS = 0 / # pts with ADL or G8 score | |
ADL Score | ||
Baseline | ||
≤5 | 12/52 | 6/20 |
>5 | 83/194 | 45/99 |
(P < 0.0001) | (P = 0.0012) | |
6 month | ||
≤5 | 5/24 | 2/16 |
>5 | 40/95 | 36/80 |
(P < 0.0001) | (P < 0.0001) | |
G8 Score | ||
Baseline | ||
≤14 | 48/149 | 25/74 |
>14 | 46/95 | 23/40 |
(P = 0.0023) | (P = 0.0335) | |
6 month | ||
≤14 | 24/76 | 20/62 |
>14 | 19/38 | 18/32 |
(P = 0.0699) | (P = 0.0506) |
ADL=activities of daily living; ECOG=Eastern Cooperative Oncology Group; G8=Geriatric 8; PS=performance status. P value from the Fisher’s exact test on the association of either ADL (≤5, >5) or G8 (≤14, >14) with ECOG PS at the specified timepoint. ECOG PS = 0 represents “fully active, able to carry on all pre-disease performance without restriction.”
Conclusions
In this subanalysis of geriatric pts from the ongoing POLARIS study associations were found between ECOG PS and frailty and functional status as assessed by G8 and ADL. G8 and ADL scores were generally maintained during the first 6 mo of therapy, indicating functional status was preserved in this elderly population receiving PAL.
Clinical trial identification
NCT03280303.
Editorial acknowledgement
Editorial support was provided by Catherine Grillo of Complete Healthcare Communications, LLC (North Wales, PA), a CHC Group company, and was funded by Pfizer Inc.
Legal entity responsible for the study
Pfizer Inc.
Funding
Pfizer Inc.
Disclosure
M.S. Karuturi: Advisory / Consultancy: Pfizer Inc. J.L. Blum: Advisory / Consultancy: Pfizer Inc. B. Telivala: Research grant / Funding (self): Cancer Specialists of North Florida. A. Bardia: Advisory / Consultancy: Novartis; Advisory / Consultancy: Pfizer Inc; Advisory / Consultancy: Spectrum Pharma. J.C. Cappelleri: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. E. Richardson: Full / Part-time employment: CPi Global CRO. Y. Wang: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer Inc. D. Tripathy: Advisory / Consultancy, Research grant / Funding (self): Novartis; Advisory / Consultancy, Research grant / Funding (self): Pfizer Inc. All other authors have declared no conflicts of interest.
Resources from the same session
3034 - Efficacy and safety of neoadjuvant chemotherapy plus trastuzumab and pertuzumab in non-metastatic HER2-positive breast cancer in real life: NEOPEARL STUDY
Presenter: Maria Agnese Fabbri
Session: Poster Display session 2
Resources:
Abstract
4772 - Real world comparison of the impact of adjuvant capecitabine in women with high-risk triple-negative breast cancer after neoadjuvant chemotherapy
Presenter: Maysa Vilbert
Session: Poster Display session 2
Resources:
Abstract
5627 - Influence of age on the indication of adjuvant chemotherapy in early breast cancer using Oncotype DX. An analysis of 240 patients treated in the Institut Catala d’Oncologia (ICO) hospitals
Presenter: Sabela Recalde
Session: Poster Display session 2
Resources:
Abstract
3917 - Impact of delayed neoadjuvant systemic chemotherapy on survival among breast cancer patients
Presenter: Mariana Chavez Mac Gregor
Session: Poster Display session 2
Resources:
Abstract
2246 - Clinical Confirmation of Higher Exposure to Niraparib in Tumor vs Plasma in Patients With Breast Cancer
Presenter: Laura Spring
Session: Poster Display session 2
Resources:
Abstract
581 - The rationale for the effectiveness of systemic treatment of breast cancer depending on the body weight index
Presenter: Mohammad Hojouj
Session: Poster Display session 2
Resources:
Abstract
5327 - Response to neoadjuvant chemotherapy in HER2 non-overexpressing breast cancer subtypes
Presenter: Silvia Mihaela Ilie
Session: Poster Display session 2
Resources:
Abstract
3613 - Pre-specified interim analysis of the SAFE trial (NCT2236806): a 4-arm randomized, double-blind, controlled study evaluating the efficacy and safety of cardiotoxicity prevention in non-metastatic breast cancer patients treated with anthracyclines with or without trastuzumab.
Presenter: Lorenzo Livi
Session: Poster Display session 2
Resources:
Abstract
3736 - Safety of hypofractionated whole breast irradiation after conservative surgery for patients aged less than 60 years: a multi-center comparative study.
Presenter: Icro Meattini
Session: Poster Display session 2
Resources:
Abstract
5085 - Usefulness of NT-ProBNP as a biomarker of cardiotoxicity in breast cancer patients treated with trastuzumab
Presenter: Isabel Blancas López-Barajas
Session: Poster Display session 2
Resources:
Abstract